A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV)

• Progression during or within 3 months following the last administration of standardchemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin.Patients treated with oxaliplatin or irinotecan in an adjuvant setting should haveprogressed during or within 6 months of completion of adjuvant therapy

• Patients who are candidates for and have access to anti-VEGF therapy (i.e. bevacizumaband regorafenib) and anti-EGFR therapy (i.e. cetuximab and panitumumab) and/or TAS-102must have received appropriate therapy.

• Patients with measurable or non measurable disease

• Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1

• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Anti-cancer chemotherapy, biologic therapy or any other systemic therapy ifadministered prior to the first planned dose of study medication within period of timeequivalent to the usual cycle length of the regimen. An exception is made for oralfluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dosemust be observed prior to the first planned dose of protocol treatment.

• Major surgery within 4 weeks prior to randomization.

• Any known brain or leptomeningeal metastases are excluded, even if treated.

• Known hypersensitivity to 5-FU/LV or patients who as a result of toxicity had toreduce or stop 5-FU infusion at the dose of 900 mg/m^2/day (total 1800 mg/m^2/day).

• Known hypersensitivity to irinotecan or patients who as a result of toxicity had toreduce or stop irinotecan infusion at the dose of 120 mg/m^2.

• Known history of human immunodeficiency virus (HIV) infection. Known chronic hepatitisB or C active infection.

• Known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

• Patients with QTc interval > 470 millisecond.

• Uncontrolled intercurrent illness